EVERA MRI ICD, S DR, XT DR ICD, XT VR ICD, INTRINSIC 30 ICD, MARQUIS VR ICD, MAXIMO II ICD, PROTECTA ICD, PROTECTA XT IC
FDA premarket approval P980016/S556 · decided 2015-12-08
Approval details
- PMA number
- P980016
- Supplement
- S556
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- EVERA MRI ICD, S DR, XT DR ICD, XT VR ICD, INTRINSIC 30 ICD, MARQUIS VR ICD, MAXIMO II ICD, PROTECTA ICD, PROTECTA XT IC
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2015-10-16
- Decision date
- 2015-12-08
- Days to decision
- 53 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR FIRMWARE UPDATES TO THE MYCARELINK PATIENT HOME MONITOR.
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